DIRECTIVE 2011/65/EU REACH - TURI...DIRECTIVE 2011/65/EU-REACH. What You Need to Know. Ken Stanvick. SVP – Co Founder. ... ¾General Principles of the CE Marking ¾Rules and Conditions

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DIRECTIVE 2011/65/EU - REACHWhat You Need to Know

Ken Stanvick

SVP – Co [email protected]

Copyright © 2011 Design Chain Associates, LLCAll Rights Reserved 2

Agenda

EU RoHS Today

EU RoHS Recast

Scope

Definitions

Product Exclusions

Prevention

Inclusions/Exemptions

Review / Amendment of Restricted Substances

Obligations of Manufacturers

Authorised Representatives

Obligations of Importers


Agenda

EU RoHS RecastObligations of Distributors

Importers and Distributors Considered Manufacturers

Identification of Economic Operators

EC Declaration of Conformity

General Principles of the CE Marking

Rules and Conditions for Affixing the CE Marking

Presumption of Conformity

Future RoHS Review

Entry Into force & Transposition


AgendaCE Marking overview

Regulation (EC) No 768/2008

General Principles Article 1

Definitions Article R1

Obligations of Manufacturers Article R2

CONFORMITY ASSESSMENT PROCEDURES ANNEX II• Module A Internal production control • Technical documentation • Manufacturing • Conformity marking and declaration of conformity • Authorised representative

Affixing of the CE Marking

Guide to the implementation of directives based on the New Approach and the Global Approach

http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf

EU REACH Update




INCOMPLETE Environmental Regulatory Landscape “Snapshot”


Growth in Environmental Regulations

Copyright © Compliance & Risks 2011 • All Rights Reserved – Used By Permission


Environmental Compliance?Choosing the Wrong Supplier or Part Used to Only Have Cost, Quality and sometimes Production ConsequencesNow it ALSO has LEGAL and Revenue Consequences


Major Drivers

Compliance Reporting

Material Restrictions

Material Content Disclosure

Producer Responsibility – End of Life – WEEE

ECO Friendly


EnvironmentalCompliance

Business Environment

Environmental Compliance Impact

CustomersCompetitors

InvestorsLegal

ContractsNew Part IntroComponent DataProduct Lifecycle

DesignersComponent

EngineersMFG Engineers

PurchasingField Service

Inventory ControlPart Identification

MFG MaterialsMaterial Declaration

Last Time BuyProduct Redesign

Agency CertificationReliability Testing

Design For EnvironmentComponent QualificationApplication Software

AssemblyTest

InspectionRework

Wave SolderReflow

Soldering Irons


RoHS Today –> RoHS RecastRoHS Directive Today RoHS Recast

Scope: 8 Categories Scope: 11 Categories

“Primary Function” “At Least One Intended Function”

No Reference to REACH Review and Amendment of Annex II must be coherent with REACH

No Defined Maximum Validity Period For Exemptions Defined Maximum Validity Period For Exemptions

No Defined Process For Renewing Exemptions Defined Process For Renewing Exemptions

No CE Marking CE Marking Required

No Signed Declaration Of Conformity Statement Signed Declaration Of Conformity Statement Required

No Technical Document Technical Document Required

Data Retention 4 Years (Guidance) Data Retention 10 Years (Legislated)

No Defined Obligations For Manufactures, Distributors, Importers Defined Obligations For Manufactures, Distributors, Importers


RoHS Recast

DIRECTIVE 2011/65/EUDate of entry into force

7/21/2011


Precautionary PrincipleThe annexes to this Directive should be reviewed periodically to take into account, inter alia, Annexes XIV and XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency. In particular, the risks to human health and the environment arising from the use of Hexabromocyclododecane (HBCDD), Bis (2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP) and Dibutylphthalate (DBP) should be considered as a priority. With a view to further restriction of substances, the Commission should re-investigate the substances, which were subject to previous assessments, in accordance with the new criteria of this Directive as part of the first review.

Note – all are SVHCs under REACH and as such must be disclosed in articles containing SVHCs >0.1%W / W

Link to DIRECTIVE 2011/65/EUhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF


Precautionary PrincipleHexabromocyclododecane (HBCD or HBCDD)

a brominated flame retardantpackaging material, video cassette recorder housing and electric and electronic equipment

Bis(2-ethylhexyl)phthalate, DEHPwidely used as a plasticizer in manufacturing of articles made of PVCas a dielectric fluid in capacitors

Benzylbutylphthalate (BBzP), also called n-butyl benzyl phthalate (BBP) or benzyl butyl phthalate, is a phthalate

trade names e.g. Palatinol BB, Unimoll BB, Sicol 160, or Santicizer 160widely used as a plasticizer in manufacturing of articles made of PVC

Dibutyl phthalate (DBP) widely used as a plasticizer in manufacturing of articles made of PVCan additive to adhesives or printing inks


SCOPE

RoHS Recast > DIRECTIVE 2011/65/EU

Article 2 Scope

1. Large household appliances

2. Small household appliances

3. IT and telecommunications equipment

4. Consumer equipment

5. Lighting equipment

6. Electrical and electronic tools (with the exception of large-scale stationary industrial tools)


SCOPE

Article 2 Scope7. Toys, leisure and sports equipment

8. Medical devices• three years after the date of entry into force• in vitro medical devices

• five years after the date of entry into force9. Monitoring and control instruments

• three years after the date of entry into force• industrial monitoring and control instruments

• six years after the date of entry into force

10. Automatic dispensers

11. Other electrical and electronic equipment not covered by any of the categories above .

• date of entry into force plus 8 years


RoHS Decision Tree for Products(Jan 3 2013)

http://publications.orgalime.org.

http://publications.orgalime.org/


Definitions

Article 3 Definitions : (selected examples)

1) ‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;

(2) for the purposes of point 1, ‘dependent ‘ means, with regard to EEE, needing electric currents or electromagnetic fields to fulfil at least one intended function;


Definitions


"large scale stationary industrial tools" means a large size assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;

"large scale fixed installation” means a large size combination of several types of apparatus and, where applicable, other devices, which are assembled, installed by professionals and intended to be used permanently in a pre-defined and dedicated location, and to be de-installed by professionals;


Definitions

Article 3 Definitions : (selected examples)"cables" means all cables with a rated voltage of less than 250V that serve as a connection or an extension to connect EEE to the electrical outlet or to connect two or more EEE to each other;

"manufacturer” means any natural or legal person who manufactures an EEE or who has an EEE designed or manufactured and markets it under his name or trademark;

“distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EEE available on the market;

“importer” means any natural or legal person established within the EU, who places an EEE from a third country on the Union market;


Definitions

Article 3 Definitions : (selected examples)"economic operators" means the manufacturer, the authorised representative, the importer and the distributor;

"making available on the market” means any supply of an EEE for distribution, consumption or use on the Unionmarket in the course of a commercial activity, whether in return for payment or free of charge;

"technical specification" means a document that prescribes technical requirements to be fulfilled by a product, process or service;

"authorised representative" means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;


Definitions


"CE marking” means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

“conformity assessment” means the process demonstrating whether the requirements of this Directive relating to an EEE, are met;

"recall" means any measure aimed at achieving the return of a product that has already been made available to the end user;


Definitions


"industrial monitoring and control instruments" mean monitoring and control instruments designed for exclusively industrial or professional use;

“availability of a substitute” means that the substitute can be manufactured and delivered within a reasonable period of time as compared with the time required for manufacturing and delivering the substances listed in Annex II


Definitions


“reliability of a substitute” means the probability that an EEE using a substitute will perform a required function without failure under a stated condition for a stated period of time;

“spare part” means a separate part of an EEE that can replace a part of an EEE. The EEE cannot function as intended without that part of the EEE. The functionality of EEE remains unchanged or is upgraded when the part is replaced by a spare part


Product Exclusions

This Directive does not apply to: (selected examples)

Equipment which is specifically designed and to be installed as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can only be replaced by the same specifically designed equipment;

Large-scale stationary industrial tools;

Large scale fixed installations;

Active implantable medical devices;


Product Exclusions

This Directive does not apply to: (selected examples)

Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications;

Equipment specifically designed solely for the purposes of research and development only made available on a business to business basis.

Equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war material intended for specifically military purposes;


Prevention

Member States shall ensure that EEE placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, does not contain the substances listed in Annex II.

Paragraph 1 shall apply to

medical devices and monitoring and control instrumentswhich are placed on the market from three years after the date of entry into force of this Directive

in vitro medical devices which are placed on the market fromfive years after the date of entry into force of this Directive

industrial monitoring and control instruments which are placed on the market from six years after the date of entry into force of this Directive


PreventionMember States shall ensure that EEE placed on the market,including cables and spare parts for its repair, its reuse,updating of its functionalities or upgrading of its capacity, does not contain the substances listed in Annex II.

Paragraph 1 shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading ofcapacity of the following

EEE placed on the market before 1 July 2006;

medical devices placed on the market before three years after the date of entry into force of this Directive

in vitro diagnostic medical devices placed on the market beforefive years after the date of entry into force of this Directive

EEE which benefited from an exemption and was placed on themarket before that exemption expired as far as that specificexemption is concerned.


Prevention

Member States shall ensure that EEE placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, does not contain the substances listed in Annex II.

Paragraph 1 shall not apply to the re-use of spare parts recovered from EEE put on the market before 1 July 2006, under the condition that re-use takes place in auditableclosed-loop business-to-business return systems, and that re-use of parts is notified to the consumer.


Inclusions / Exemptions

For the purposes of adapting Annexes III and IV to scientific and technical progress, and in order to achieve the objectives set out in Article 1, the Commission shall adopt by means of individual delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22 , the following measures:

inclusion of materials and components of EEE for specific applications in Annexes III and IV on exemptions if such inclusion does not weaken the environmental and health protection of Regulation (EC) No 1907/2006 (REACH) andwhere any of the following conditions is fulfilled

their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to in Article 4(1) is scientifically or technically impracticable;

the reliability of substitutes is not ensured



inclusion of materials and components of EEE for specific applications in Annexes III and IV on exemptions if such inclusion does not weaken the environmental and health protection of Regulation (EC) No 1907/2006 and where any of the following conditions is fulfilled

the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the totalenvironmental, health and consumer safety benefits thereof;

The decision on inclusion of materials and components of EEE in Annexes III and IV on exemptions and the length of possible exemptions shall take into account the availability of substitutesand the socio-economic impact of substitution. Decisions on the length of possible exemptions shall take into account any potential adverse impacts on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant



Measures adopted in accordance with point (a) of paragraph 1 shall, for categories 1 to 7, 10 and 11 of Annex I, have a validity period of up to five years and, for categories 8 and 9 of Annex I, a validity period of up to seven years, to be decidedon a case-by-case basis and which can be renewed.

For the exemptions listed in Annex III on,date of entry into force, the maximum validity period, which can be renewed, shall, for categories 1 to 7 and 10 of Annex I, be five years from the date of entry into force of this Directive and, for categories 8 and 9 of Annex I, seven years from the dates laid down in Article 4(3), unless a shorter period is specified.

For the exemptions listed in Annex IV, medical and monitoring, on, date of entry into force, the maximum validity period, which can be renewed, shall be seven years from the dates laid down in Article 4(3), unless a shorter period is specified

Annex IV, Applications exempted from the restriction in Article 4(1) specific to medical devices and monitoring and control instruments



An application for granting, renewing or deleting an exemption shall be made to the Commission in accordance with Annex V

Applications for exemptions, renewal of exemptions or, mutatismutandis, for deleting an exemption may be submitted by a manufacturer, the authorised representative of a manufacturer, or any actor in the supply chain and shall include at least the following:

the name, address and contact details of the applicant;

information on the material or component and the specific uses of the substance in the material and component for which an exemption, or its deletion, is requested and its particular characteristics;

verifiable and referenced justification for an exemption, or its deletion, in line with the conditions established in Article 5;1. Mutatis mutandis is a Latin phrase meaning "by changing those

things which need to be changed" or more simply "the necessary changes having been made".

2. en.wikipedia.org/wiki/Mutatis_mutandis



Applications for exemptions, renewal of exemptions or, mutatis mutandis, for deleting an exemption may be submitted by a manufacturer, the authorised representative of a manufacturer, or any actor in the supply chain and shall include at least the following:

an analysis of possible alternative substances, materials or designs on a life-cycle basis, including, when available, information about independent research, peer-review studies and development activities by the applicant and an analysis of the availability of such alternatives;

information on the possible preparing for re-use, recycling of materials from waste EEE, the appropriate treatment provisions according to Annex II of Directive (…/…) of the European Parliament and of the Council on waste electrical and electronic equipment (WEEE);

other relevant information;



Applications for exemptions, renewal of exemptions or, mutatis mutandis, for deleting an exemption may be submitted by a manufacturer, the authorised representative of a manufacturer, or any actor in the supply chain and shall include at least the following:

the proposed actions to develop, request the development and/or to apply possible alternatives including a timetable for such actions by the applicant;

where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;

when applying for an exemption, proposal for a precise and clear wording for the exemption

a summary of the application.



An application for granting, renewing or deleting an exemption shall be made to the Commission in accordance with Annex V

The Commission shall:

acknowledge receipt of an application in writing within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application;

inform without delay the Member States of the application and shall make the application and any supplementary information supplied by the applicant available to them;

make a summary of the application available to the public;

evaluate the application and its justification

An application for renewal shall be made no later than 18 months before an exemption expires.



The Commission shall decide on an application for renewal no later than 6 months before the expiry date of the existing exemption unless specific circumstances justify other deadlines. The existing exemption shall in any case remain valid until a decision on the renewal application is taken by the Commission.

In the event that the application for renewal is rejected or that an exemption is deleted, there shall be a minimum period of12 months and maximum period of 18 months from the date the decision is taken before the exemption expires.

Before Annexes are amended, the Commission shall inter alia consult economic operators, recyclers, treatment operators, environmental organisations and employee and consumerassociations and make the comments received publicly available.



The review and amendment of the list of restricted substances in Annex II shall be coherent with other legislation related to chemicals, in particular Regulation (EC) No 1907/2006 (REACH) and shall take into account, inter alia, Annexes XIV and XVII to that Regulation. The review should use publicly available knowledge obtained from the application of such legislation

To review and amend Annex II, the Commission shall take special account of whether a substance, including substances of verysmall size or internal or surface structure, or a group of similar substances:

could have a negative impact during EEE waste management operations, including on the possibilities for preparing for the reuse of waste EEE or for recycling of materials from waste EEE;

could give rise, given its uses, to uncontrolled or diffuse release to the environment of the substance or could give rise to hazardous residues or transformation or degradation products through the preparing for re-use, recycling or other treatment of materials from waste EEE under current operational conditions;



With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and amendment of the list of restrictedsubstances in Annex II shall be considered by the Commission before 3 years after the entry into force of this Directive and periodically thereafter on its own initiative or following the submission of a proposal by a Member State containing the information referred to in paragraph 2

To review and amend Annex II, the Commission shall take special account of whether a substance, including substances of very small size ( Nonomaterial? ) or internal or surface structure, or a group of similar substances:

could lead to unacceptable exposure of workers involved in the waste EEE collection or treatment processes;

could be replaced by substitutes or alternative technologies which have less negative impacts.



The proposals to review and amend the list of restricted substances, or a group of similar substances, in Annex II shall contain at least the following information:

precise and clear wording of the proposal;

referenced and scientific evidence for the restriction;

information on the use of the substance or the group of similar substances in EEE;

information on detrimental effects and exposure in particular during waste EEE management operations;

information on possible substitutes and other alternatives, their availability and reliability;

justification for considering a Union-wide restriction as the most appropriate measure;

socio-economic assessment



Member States shall ensure that:

when placing EEE on the market, manufacturers ensure that they have been designed and manufactured in accordance with the requirements set out in Article 4( Prevention);

manufacturers draw up the required technical documentation and carry out the internal production control procedure in line withmodule A of Annex II to Decision No 768/2008/EC or have it carried out

Where compliance of EEE with the applicable requirements has been demonstrated by that procedure, manufacturers draw up an EC declaration of conformity and affix the CE marking on the finishedproduct.

Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of this Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up;



manufacturers keep the technical documentation and the EC declaration of conformity for ten years after the EEE has been placed on the market;

manufacturers ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of EEE is declared shall be adequately taken into account;

manufacturers keep a register of non-conforming EEE and product recalls, and keep distributors informed thereof;



manufacturers ensure that their EEE bear a type, batch orserial number or other element allowing their identification, or, where the size or nature of the EEE does not allow it, that the required information is provided on the packaging or in a document accompanying the EEE;

manufacturers indicate their name, registered trade nameor registered trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE. The address must indicate a single point at which the manufacturer can be contacted;

Where other applicable Union legislation contains provisions for the affixing of the manufacturer's name and address which are at least as stringent, those provisions shall apply;



manufacturers who consider or have reason to believe that a EEE which they have placed on the market is not in conformity with this Directive immediately take the necessary correctivemeasures to bring that EEE into conformity, to withdraw it or recall it, if appropriate and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;

manufacturers , further to a reasoned request from a competent national authority, provide it with all the information anddocumentation necessary to demonstrate the conformity of the EEE, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to ensure compliance with the provisions of this Directive of EEE which they have placed on the market.


Authorised RepresentativesMember States shall ensure that:

a manufacturer has the possibility to appoint an authorised representative by written mandate.

The obligations laid down in Article 7(a) and the drawing up of technical documentation shall not form part of the authorised representative's mandate;

• "authorised representative" means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

an authorised representative performs the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for ten years after the EEE has been placed on the market;further to a reasoned request from a competent national authority, providethat authority with all the information and documentation necessary to demonstrate the conformity of an EEE with this Directive;cooperate with the competent national authorities, at their request, on any action taken to ensure compliance with the provisions of this Directive of EEE covered by their mandate.



importers place only compliant products on the Union market;

before placing an EEE on the market importers ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. Importers will further ensure that the manufacturer has drawn up the technical documentation, that the EEE bears the CE marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 7(e) and (f).

manufacturers keep a register of non-conforming EEE and product recalls, and keep distributors informed thereofmanufacturers ensure that their EEE bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the EEE does not allow it, that the required information is provided on the packaging or in a document accompanying the EEE

Where an importer considers or has reason to believe that an EEE is not in conformity with Article 4, he does not place the EEE on the market until it has been brought into conformity and inform the manufacturer and the market surveillance authorities to that effect;



importers indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE.

Where other applicable Union legislation contains provisions for the affixing of the importer's name and address which are at least as stringent, those provisions shall apply

importers, in order to ensure compliance with the provisions of this Directive, keep a register of non-compliant EEE and EEE recalls, and keep distributors informed thereof;

importers who consider or have reason to believe that an EEE which they have placed on the market is not in conformity with this Directive immediately take the corrective measures necessary to bring that EEE into conformity, to withdraw it or recall it, if appropriate and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;



importers keep, for ten years after the EEE has been placed on the market, a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request;

importers, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EEE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to ensure compliance with the provisions of this Directive of EEE which they have placed on the market.


Obligations of Distributorswhen making an EEE available on the market, distributors act with due care in relation to the requirements applicable in particular by verifying that the EEE bears the CE marking, that it is accompanied by the required documents in a language which can be easily understood by consumers and other end-users in the Member State in which the EEE is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Articles 7(f) and 7(g) and Article 9(c)

• manufacturers ensure that their EEE bear a type, batch or serial number orother element allowing their identification, or, where the size or nature of the EEE does not allow it, that the required information is provided on the packaging or in a document accompanying the EEE;

• manufacturers indicate their name, registered trade name or registeredtrade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE. The address must indicate a single point at which the manufacturer can be contacted;

• importers indicate their name, registered trade name or registered trademark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE.


Obligations of Distributorswhere a distributor considers or has reason to believe that an EEE is not in conformity with Article 4, he does not make the EEE available on the market until it has been brought into conformity,and informs the manufacturer or the importer to that effect as well as the market surveillance authorities;

distributors who consider or have reason to believe that an EEE which they have made available on the market is not in conformity with this Directive make sure that the corrective measures necessary to bring that EEE into conformity, to withdraw it or recallit, if appropriate, are taken and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;

distributors , further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of EEE. They cooperate with that authority, at its request, on any action taken to ensure compliance with the provisions of this Directive of the EEE which they have made available on the market.


Importers and Distributors Considered Manufacturers

Cases in which obligations of manufacturers apply to importers and distributors

Member States shall ensure that an importer or distributor is considered a manufacturer for the purposes of this Directive and that he is subject to the obligations of the manufacturer under Article 7, where he places EEE on the market under his name or trademark or modifies EEEalready placed on the market in such a way that compliance with the applicable requirements may be affected.


Identification of Economic Operators

Member States shall ensure that economic operators on request, identify the following to the market surveillance authorities, for ten years

any economic operator who has supplied them with an EEE;

any economic operator to whom they have supplied an EEE.

"economic operators" means the manufacturer, the authorised representative, the importer and the distributor;



The EC declaration of conformity shall state that the fulfilment of requirements specified in Article 4 (Prevention) has been demonstrated.

The EC declaration of conformity shall have the model structure and shall contain the elements specified in Annex VI and shall be updated. It shall be translated into the language orlanguages required by the Member State on the market of which the product is placed or made available.

Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of this Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up

By drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE with this Directive.



EC DECLARATION OF CONFORMITY

No … (unique identification of the EEE)

Name and address of the manufacturer or his authorised representative:

This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

Object of the declaration (identification of EEE allowing traceability. It may include a photograph, where appropriate):



EC DECLARATION OF CONFORMITYThe object of the declaration described above is in conformity with Directive …/... on the restriction of the use of certain hazardous substances in electrical and electronic equipment

Where applicable, references to the relevant harmonised standards used or references to the technical specifications in relation to which conformity is declared:

Additional information:

Signed for and on behalf of: …………………………………(place and date of issue):(name, function) (signature)



The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

The CE marking shall be affixed only by the manufacturer or his authorised representative.

The CE marking as presented in Annex II shall be affixedonly to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.

By affixing or having affixed the CE marking, themanufacturer indicates that he takes responsibility for theconformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.



The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.

The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

Without prejudice to Article 41, Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use


Rules and Conditions for Affixing the CE Marking

The CE marking shall be affixed visibly, legibly and indelibly to the finished EEE or to its data plate. Where that is not possible or not warranted on account of the nature of the EEE, it shall be affixed to the packaging and to the accompanying documents

The CE marking shall be affixed before the EEE is placed on the market.

Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.


Presumption of Conformity

In the absence of evidence to the contrary, Member States shall presume electrical and electronic equipment bearing the CE marking as conforming to this Directive.

Materials, components and EEE on which tests and measurements demonstrating compliance with the requirements of Article 4 have been performed, or which have been assessed, in accordance with harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to comply with the requirements of this Directive


Future RoHS Review

No later than 3 years after the date of entry into force of thisDirective the Commission shall examine the need to amend thescope of this Directive in respect of the EEE referred to in Article2, and shall present a report there on to the EuropeanParliament and the Council accompanied by a legislativeproposal, if appropriate, with respect to any additionalexclusions related to that EEE.

No later than 10 years after the date of entry into force of thisDirective the Commission shall carry out a general review of thisDirective, and shall present a report to the European Parliamentand the Council accompanied, if appropriate,by a legislativeproposal.


Entry Into force & Transposition

This Directive shall enter into force on the 20th dayfollowing that of its publication in the Official Journal of the European Union.

July 21 2011

Member States shall adopt and publish, by at the latest 18 months after the publication of this Directive, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions

Jan 3 2013


IMPORTANT DATES

- Orgalime Guide to understanding the specific obligations of the Recast RoHS Directive

Orgalime RoHS Guide http://publications.orgalime.org.

http://publications.orgalime.org/



General Principles Article 1

Products placed on the Community market shall comply with all applicable legislation.

When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of their products with all applicable legislation

Economic operators shall be responsible for ensuring that all information they provide with regard to their products isaccurate, complete and in compliance with Community rules applicable.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF



Definitions Article R1

‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;

‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

‘recall’ shall mean any measure aimed at achieving the return of a product that has already been made available to the end user;

‘withdrawal’ shall mean any measure aimed at preventing a product in the supply chain from being made available on the market;


Regulation (EC) No 768/2008Obligations of Manufacturers Article R2

Manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable or have it carried out.

Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken into account.

Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.



CONFORMITY ASSESSMENT PROCEDURES ANNEX IIModule A Internal production control

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:



Technical documentation

a general description of the product

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product

a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied

results of design calculations made, examinations carried out, etc

test reports


Regulation (EC) No 768/2008Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the legislative instruments that apply to them.

Conformity marking and declaration of conformityThe manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrumentThe manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up.A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

Authorised representativeThe manufacturer's obligations, Conformity marking and declaration of conformity, may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate


Affixing of the CE Marking

The CE marking must be affixed by the manufacturer, or by the authorised representative established within the Community

The CE marking must take the form below. If the CE marking is reduced or enlarged the proportions must be respected.


Affixing of the CE MarkingThe CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents.

the requirement for visibility means that the CE marking must be easily accessible for all parties. It could, for instance, be affixed on the back or underside of a product. A minimum height of 5 mm is required to ensure that it is legible

It shall also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces (for example some product standards use a rub test with water and petroleum spirits). However, this does not mean that the CE marking must form an integral part of the product.Additional information

Guide to the implementation of directives based on the New Approach and the Global Approach

• http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf




EU REACH Update

Registration, Evaluation, Authorization, and Restriction of Chemicals


The 0.1% w/w Limit Controversy


Nordic Council Report

“REACH Trigger for Information on Substances of Very High Concern (SVHC)”

“As Assessment of the 0.1% Limit in Articles”TemaNord 2010:514

Based on disagreement with Commission Legal Service’s definition of “article”Seeks to differentiate “complex article” comprised of other “articles” and influence the Guidance document

Examples provided of how many “tonnes” of SVHCs could be put on the market without disclosure triggers based on the current definition

Would apply the 0.1% wt limit for candidate SVHC disclosure per Article 33 to components that are articles themselves

But not homogeneous materials, as in RoHSSee http://www.norden.org

http://www.norden.org/


Electronics Example: Current Interpretation

TemaNord 2010:514 © Nordic Council of Ministers, Copenhagen 2010


Electronics Example: NC Preferred Interpretation

TemaNord 2010:514 © Nordic Council of Ministers, Copenhagen 2010


What’s Next for 0.1%?

Both sides of the argument were presented at the Feb 8-9 CARACAL meeting

Commission Legal Service reiterated their interpretation: 0.1% applies to the entire article

ECHA published the guidance in April as it is without the footnote referring to the dissenting views of six Member States

In June, France unilaterally announced it will enforce the “once an article, always an article” approach


Candidates for What?

Candidates for prioritization and inclusion in the List of Substances Subject to Authorization

(Annex XIV of REACH)

These are substances that have been identified as meeting the criteria for authorization

Defined in Article 57


Candidate List (Art. 59) History

Dates in RED are estimatesAdditional Candidate Lists of SVHCs expected twice a yearhttp://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp


Candidate List Substances to Date53 SVHCs Defined To Datehttp://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp


CMRs: Carcinogenic, Mutagenic or toxic to ReproductionDBP, DIBP:Reprotoxin - May cause harm to the fetusDEHP: Reprotoxin - May impair fertility; May cause harm to the fetusTCEP: Reprotoxin - May impair fertilityBoric Acid: Reprotoxin - May impair fertility; May cause harm to the fetus

PBTs: Persistent, Bioaccumulative and ToxicHBCD: PBT – Toxic to Daphnia (ecosystem “indicator species”), Very Bioaccumlative (vB), long half-life (>120 days) in soil; found in many places (can travel)

vPvBs: Very Persistent or Very BioaccumulativeSCCPs:PBT & vPvB - vP due to half life in fresh water/sediment > 180 days; vB in fish; Toxic to Daphnia magna

Substances of equivalent level of concernSome in group 4

Why These are Considered SVHCs


The Authorization Process

ECHA Committees:RA: Risk AssessmentSEA: Socio-Economic Analysis


Annex XIV Substances #1

Timetable30 June 2010: Commission issues Draft Regulation updating Annex XIV to WTO30 Aug 2010: End of comment period17 Feb 2011: “Date of Inclusion” (application period begins) per Commission Regulation 143/2011


Proposed Annex XIV Substances #2

Two from first SVHC list; remainder from second listProposed by ECHA on 1 July 2010Comment period through 30 Sept 2010Submitted to EC 20 Dec 2010Anticipated DoI: November 2011


Proposed Annex XIV Substances #3

90 Day Comment Period opened 6/15/2011http://echa.europa.eu/consultations/authorisation/draft_recommendations/recommendations_en.asp


Authorization & Imported Articles

Substances that are an integral part of imported articles are not subject to Authorization

So you can import articles into the EU that incorporate authorized substances WITHOUT having an authorization in the supply chain

But they are subject to Restriction

Imported products containing SVHCs on the Candidate List are still subject to notification (art 7.2) article 33-related communication, and to restrictions (Annex XVII)


Article 69 – Closing the Loophole

The EC can request ECHA to produce an Annex XV Dossier on substances in articlesIf ECHA determines that risk is not “adequately controlled” they will produce a dossier after the Sunset DateIf the Agency suggests restrictions as an appropriate response, the restriction process will begin

Member States can also initiate Annex XV Dossiers for similar purposeDenmark has done so for 4 Phthalates – comments open now

Buys time…sometimes


Thank You For Your Attention

Questions ?

Documents

DIRECTIVE 2011/65/EU REACH - TURI...DIRECTIVE 2011/65/EU-REACH. What You Need to Know. Ken Stanvick. SVP – Co Founder. ... ¾General Principles of the CE Marking ¾Rules and Conditions